Advancing type 1 diabetes therapy: autologous islet transplant breakthrough.
Ram Abou Zaki, Assam El-Osta
https://pubmed.ncbi.nlm.nih.gov/39710778Actively Recruiting
Phase 2
Phase 3
Age: 15Years - 18Years
All Genders
ID06951074
Autologous Insulin Producing Mesenchymal Stem Cell Transplantation in Youth With Type 1 Diabetes
Led by Ain Shams University · Updated on 2025-04-30
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Type 1 Diabetes is a chronic autoimmune condition caused by the destruction of pancreatic Beta cells, leading to a total lack of insulin. Researchers are studying the use of stem cells derived from adipose tissue mesenchymal origin to develop insulin-producing cells as a potential new treatment. This study evaluates autologous insulin-producing mesenchymal stem cells in youth with type 1 diabetes, aiming to improve blood sugar control and reduce dependence on standard treatments. The trial involves collecting fat tissue from participants through liposuction, then isolating and differentiating mesenchymal stem cells into insulin-producing cells in the lab. Participants receive these cells by injection either into the portal vein or into the peripheral bloodstream. The study compares these two delivery methods and monitors the ability of these cells to produce insulin both in the lab and in the body over one year. Participants will undergo assessments including lab tests to measure insulin and C-peptide release in response to glucose. Researchers will track blood sugar control after the transplant and follow participants for one year to evaluate the effectiveness and safety of the treatment. The study lasts for one year after transplantation, with ongoing monitoring to understand the benefits and risks of this innovative therapy.
CONDITIONS
Brief Title
Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes
Who Can Participate
Age: 15Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 1 diabetes
- Age between 15 and 18 years
- All genders are eligible
You will not qualify if you...
- Presence of other autoimmune diseases
- Presence of microvascular or macrovascular complications
- Presence of other chronic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session with follow-up lasting up to 1 year
Participants undergo liposuction to collect adipose tissue, followed by differentiation of mesenchymal stem cells into insulin-producing cells and infusion of these cells either into the portal or peripheral systemic circulation.
1 treatment visit and multiple follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Children Hospital Eldemerdash
Cairo, Egypt
Actively Recruiting
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Research Team
R
Rasha S Elmetwally, MD
R
Rasha S Eladawy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Autologous Mesenchymal Stem Cell Transplant in Patients with Type 1 Diabetes Mellitus.
Olga Ulyanova, Manarbek Askarov, Larissa Kozina...
https://pubmed.ncbi.nlm.nih.gov/30777564The Role of Mesenchymal Stem Cells in the Treatment of Type 1 Diabetes.
Maleesha Jayasinghe, Omesh Prathiraja, Prashan B Perera...
https://pubmed.ncbi.nlm.nih.gov/36042996